BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALLANT HF

    MDR report key: 23118237 · Received September 22, 2025

    Report

    Report Number
    2017865-2025-18207
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    July 4, 2025
    Report Date
    May 28, 2026
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEW INFORMATION INDICATES THAT ANOTHER OCCURRENCE OF POST-PACED T-WAVE OVERSENSING WAS NOTED ON THE DEVICE. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 0

    NEW INFORMATION INDICATES THAT THE EPISODES OF T-WAVE OVERSENSING WERE ISOLATED AND OCCURRED OVER A SHORT TIME PERIOD. NO CHANGES WERE MADE. THE PATIENT WAS ASYMPTOMATIC AND WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED POST PACED T WAVE OVERSENSING ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). NO CHANGES OR INTERVENTIONS WERE PERFORMED. THE PATIENT CONDITION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261510 GALLANT HF NO MATCH NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CDHFA500Q P000204375

    Patients

    Seq Age Sex Outcome Treatment
    1